levofloxacin 500 mg/100mL
levofloxacin · INJECTION, SOLUTION · Gland Pharma Limited
levofloxacin is a injection, solution containing levofloxacin at 500 mg/100mL, taken intravenous. Manufactured by Gland Pharma Limited.
Key Facts
- Brand Name
- levofloxacin
- Generic Name
- levofloxacin
- NDC Code (Product)
68083-415- Manufacturer
- Gland Pharma Limited
- Strength
- 500 mg/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206908
- Drug Class
- Fluoroquinolone Antibacterial [EPC]
- Marketing Start
- 12/30/2020
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Akorn, Inc.
CGMP Deviations:
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Actavis Inc
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
AuroMedics Pharma LLC
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Frequently Asked Questions
What is levofloxacin used for?
levofloxacin contains levofloxacin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is levofloxacin a controlled substance?
levofloxacin is not classified as a controlled substance by the DEA.
What is the generic name for levofloxacin?
The generic name for levofloxacin is levofloxacin. There are 10 other brand versions of levofloxacin.
What is the NDC code for levofloxacin 500 mg/100mL?
The NDC (National Drug Code) for levofloxacin 500 mg/100mL is 68083-415, listed by Gland Pharma Limited.
Other levofloxacin Dosages
Other Levofloxacin Brands
See all →- Levofloxacin500 mg/180425-0008
- Levofloxacin250 mg/10904-6351
- Levofloxacin750 mg/131722-723
- Levofloxacin750 mg/143063-459
- Levofloxacin250 mg/150090-3245
- Levofloxacin250 mg/151655-947
- Levofloxacin250 mg/155111-279
- Levofloxacin750 mg/30mL55150-157
- Levofloxacin500 mg/100mL55150-244
- Levofloxacin750 mg/150mL55150-245
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)